Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare

September 6, 2015 updated by: SoberLink, LLC
This is an exempt, retrospective study of a limited set of information obtained from patients' medical records at 10 to 12 substance abuse treatment programs combined with alcohol breath analyzer results during up to 3 years of aftercare monitoring. The study objectives are 1) to compare the compliance rates and likelihood of achieving sustained sobriety for aftercare patients in mandated (eg, impaired professionals) versus non-mandated monitoring programs and 2) identify components within patients' monitoring agreements that are significantly correlated with positive outcomes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Juno Beach, Florida, United States, 33408
        • Ed Pigott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Alcohol abusers enrolled into an aftercare program following residential treatment for alcohol abuse

Description

Inclusion Criteria:

  • Adults with a diagnosis of alcohol abuse enrolled into an aftercare program following residential treatment

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mandated impaired professionals
Physicians and other licensed healthcare professionals in mandated monitoring programs by State licensing boards due to Alcohol Use Disorder who are treated with Soberlink combined with aftercare services following residential treatment.
Other: Soberlink combined with aftercare services
Soberlink Alcohol Breath Analyzer System combined with aftercare services
Non-mandated adults
A general population of adults in aftercare following residential treatment for Alcohol Use Disorder who are treated with Soberlink combined with aftercare services following residential treatment.
Other: Soberlink combined with aftercare services
Soberlink Alcohol Breath Analyzer System combined with aftercare services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compliance rates (negative versus positive versus false positive alcohol test findings)
Time Frame: Test administered 2 to 4 times per day for up to 3 years
Test administered 2 to 4 times per day for up to 3 years
Response rates: defined as use of device when prompted-will include several values such as missed, late, excused
Time Frame: Test administered 2 to 4 times per day for up to 3 years
Test administered 2 to 4 times per day for up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SoberLink, LLC

Investigators

  • Principal Investigator: Ed Pigott, Ph.D., Mr. Pigott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 6, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 6, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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